BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 4133235 · Received October 1, 2014

    Report

    Report Number
    1061932-2014-02469
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 2, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE REPORTED AN ISSUE WITH THE BATH DRAIN OR NEEDLE VENT BACKWASHING SYSTEMS. THE FSE REPLACED SOLENOID PINCH VALVES 3, 18, AND 19 THAT WERE SLOW TO ACTUATE AS WELL AS THE CBC WASTE CHAMBER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUSLY HIGH COMPLETE BLOOD COUNT (CBC) RESULTS WERE RECOVERED FOR ONE PATIENT SAMPLE PROCESSED ON A COULTER LH 500 HEMATOLOGY ANALYZER. AT THE TIME OF THE EVENT, THE CUSTOMER WAS TESTING ALL PATIENT SAMPLES IN DUPLICATE TO VERIFY RESULTS. THE PATIENT SAMPLE'S FIRST RERUN RESULTS RECOVERED LOWER FOR HEMOGLOBIN (HGB), RED BLOOD CELL (RBC), HEMATOCRIT (HCT), AND PLATELET (PLT) RESULTS WITHOUT INSTRUMENT GENERATED FLAGS WHEN COMPARED TO THE INITIAL SAMPLE RUN RESULTS. THE PATIENT SAMPLE WAS RETESTED ON THE SAME INSTRUMENT AND THE SECOND AND THIRD RERUN RESULTS WERE SIMILAR TO THE INITIAL RESULTS. THE INITIAL RESULTS, SECOND RERUN RESULTS, AND THIRD RERUN RESULTS WERE CONSIDERED CORRECT AND WERE REPORTED OUT OF THE LABORATORY. THERE WERE NO ERRONEOUS RESULTS REPORTED OUT OF THE LABORATORY. PATIENT TREATMENT WAS NOT IMPACTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611009 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1